HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU) Recall Details
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
Medical DeviceHigh riskSep 9, 2026
Confirm With The Official Notice
Use this page to screen for a possible match. Use the linked official notice before you stop use, throw away, return, repair or schedule service.
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
Before you act: a similar product name is not enough. Match the identifiers, affected dates, model or lot details, and remedy instructions in the official notice.
1. Match the item
Check device name, UDI, model, lot, serial and software version.
2. Read the risk
Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.
3. Follow the remedy
Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.
4. Verify officially
Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.
How To Tell If Yours Is Included
Device recalls can depend on UDI, model, catalog number, lot, serial number, software version or implant card details. Match the label before changing device use.
Recall Hazard And Risk
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
Recall Remedy
Use the official notice for remedy instructions. Product recall remedies may include repair, replacement, refund, disposal, software update, dealer service or a stop-use instruction.
Affected Product Or Item
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
Hazard Or Reason For Recall
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
How To Check If This Recall Applies To You
Match The Device Label
Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.
Compare Codes And Date Ranges
Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.
Read The Hazard Before Use
Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.
Follow The Official Remedy
Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.
Key Medical Device Recall Checks
Use these checks to decide whether the notice is relevant to the item you have, then confirm with the official source.
Identity
UDI, Model, Lot And Serial
Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.
Risk
Hazard, Consequence And Risk Level
Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.
Action
Repair, Replacement, Refund Or Disposal
Recall remedies differ by agency and product type. The official notice is the final source for repair, refund, replacement, disposal, dealer service or stop-use steps.
Source
Official Agency Notice
This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to a resident/patient fall and serious injury, such as head injury, fractures, or other trauma resulting from a patient fall.
Short answers for checking whether this recall notice applies to your item.
How do I know if this recall affects my product?
Compare the product name, brand, model, UPC, lot code, serial number, VIN, date code, package size, retailer and distribution details with the official notice. All key details should match.
What should I do after finding a matching recall?
Stop using, feeding, driving or consuming the product when the notice says to do so, then follow the official remedy for repair, replacement, refund, disposal, service or company contact.
Is this page the official recall notice?
No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.
Why can a recall page change after publication?
Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.